JPRN-C000000325CompletedPhase 1
A dose finding study of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation - A dose finding study of melphalan combined with fludarabine for UBMT (C-SHOT 0502)
agoya Blood and Marrow Transplantation Group0 sites20 target enrollmentStarted: February 7, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 40years-old to 65years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1) Positive for HIV antibody and/or HBs antigen and/or HCV antibody, (2) Graft manipulation such as T cell depletion, (3) Pregnant or during breast feeding, (4) Uncontrolled psychiatric disease, (5) Uncontrolled active infection, (6) Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, (7) Available of a suitable related donor, (8)Impaired organ function, (a) left ventricular ejection fraction smaller than 40%,(b) DLCO/FEV1.0/TLC equal to or less than 30%, (c) Total bil equal to or more than 2xULN (NCI-CTCAE Grade 3), (d) AST/ALT equal to or more than 5xULN (NCI-CTCAE Grade 3), (e) serum creatinine equal to or more than 3xULN (NCI-CTCAE Grade 3), (f) Karnofsky score equal to or less than 50
Investigators
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